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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K152006
Device Name Cogent Hemodynamic Monitoring System
Applicant
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact Natalie Hepworth
Correspondent
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Correspondent Contact Natalie Hepworth
Regulation Number870.1120
Classification Product Code
DXQ  
Subsequent Product Code
DQA  
Date Received07/21/2015
Decision Date 05/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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